UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048478 |
|---|---|
| Receipt number | R000055222 |
| Scientific Title | A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/08/14 15:57:34 |
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Basic information
Public title
A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Acronym
ACT-1 study
Scientific Title
A single-arm exploratory study for the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity
Scientific Title:Acronym
ACT-1 study
Region
| Japan |
Condition
Condition
taxane-induced peripheral neurotoxicity
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of acupuncture in patients with taxane-induced peripheral neurotoxicity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average pain intensity between baseline and week 16.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient with breast cancer who had received curative treatment more than 3 months ago
2) Received taxane.
3) Have "mild" or severer symptom in PRO-CTCAE item 39b
4) 18 years or older
5) ECOG PS 0 or 1
Key exclusion criteria
1)Patient with peripheral neuropathy by other than taxane
2)have distant metastases or local recurrence
3)have fibromyalgia, inflammatory joint disease, or phantom limb pain
4)undergoing chemotherapy
5)have mental illness
6)have severe comorbidities
7)being pregnant or breastfeeding
8)history of acupuncture for CIPN
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Satomi |
Organization
National Cancer Center Hospital
Division name
Department of Palliative Medicine
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
esatomi@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishiki |
Organization
National Cancer Center Hospital
Division name
Department of Palliative Medicine
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
hishiki@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospiatl
Department of Palliative Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055222
